Evaluation of Nevisense as Support Tool for the Diagnose of Keratinocyte Skin Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nevisense.
- Who it may be relevant to
- Registry conditions: Keratinocyte Skin Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Clinical Utility of a New Diagnostic Support Tool, Based on Electrical Impedance Spectroscopy (NEVISENSE), for Keratinocyte Skin Cancer
Overview
This is a prospective study to assess efficacy of the Nevisense device in identifying keratinocyte skin cancer (KC) in patients suspected of having skin cancer based on the initial physician's assessment. All skin lesions with a suspicion of Basal cell carcinoma (BCC), Invasive Squamos cell Carcinoma (iSCC), Bowen's disease (BD) or actinic keratosis (AK) and destined for excision or biopsy for further histopathological analysis will be considered for inclusion in the study.
Interventions
- Device Nevisense
The Nevisense system is based on Electrical Impedance Spectroscopy (EIS). EIS is a measure of the overall resistance within a skin tissue, at alternating currents of various frequencies. Since skin tissues have different electrical properties depending on cell structure and medical conditions, the resulting electrical impedance spectra will reflect the properties of the skin tissue.
Primary outcome measures
- Nevisense Sensitivity and Specificity [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- All male or female patients of any ethnicity, ≥ 18 years with skin lesions of a clinical uncertain diagnosis suspicious for KC (such as BCC, iSCC, BD or AK)
Exclusion criteria
- Metastases of recurrent lesions
- Lesion located on acral skin, e.g. sole or palm
- Lesion located on areas of scars, crusts, psoriasis or similar skin conditions
- Lesion on hair-covered areas, e.g. scalp, beards, moustaches
- Lesion located on genitalia
- Lesion located in an area that has been previously biopsied or subjected to any kind of surgical intervention or traumatized
- Lesion located on mucosal surfaces
- Lesion with foreign matter, e.g. tattoo or splinter
- Lesion and / or reference located on acute sunburn
- Skin surface not measurable, e.g. lesion on a stalk
- Skin surface not accessible, e.g. inside ears, under nails
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Germany · 1 center
- CentroDerm — Wuppertal
Identifiers
NCT: NCT06064019 · EIS-KC001